MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total

Detailed Description:

Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of RCC with clear cell component

Measurable disease

Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy

Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible

At least 28 days since the last chemotherapy

At least 28 days before the first dose of MDX 1411 since any major surgery

ECOG performance status 0-2

No known positivity for human immunodeficiency virus (HIV), Hep B or C

Exclusion Criteria:

Previous treatment with any other anti-CD70 antibody

Active infection requiring i.v systemic therapy within 28 days before first dose

Evidence of bleeding diathesis or coagulopathy

Active autoimmune disease requiring immunosuppressive therapy

Known current drug or alcohol abuse

Any underlying medical condition which will make the administration of MDX 1411 hazardous

Psychiatric illness or social situation that would preclude study compliance

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656734